ELEONOR STUDY: Insulin Glulisine in Type 2 Diabetes Mellitus. - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00272064

Purpose

The primary objective of the present study is to verify the superiority of Telecare program vs. standard SMBG program in terms of mean HbA1c value (- 0,5%) at end-point.
The secondary objectives of the study are the assessment of: changes in glycaemic and lipid profile, frequency of hypoglycaemias, changes in weight, health-related quality of life, cost-effectiveness of Telecare program vs. common ambulatory program; general safety (adverse event profile, other routine laboratory parameters).

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Insulin glulisine	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Dextrose Insulin glulisine

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Optimisation of Insulin Treatment of Type 2 Diabetes Mellitus by Telecare Assistance for Self Monitoring of Blood Glucose (SMBG).

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

to verify the superiority of Telecare program vs. standard SMBG program in terms of mean HbA1c value at end-point. [ Time Frame: At least 12 weeks from baseline (visit 3) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

to assess changes glycaemic. [ Time Frame: At least 12 weeks from baseline (visit 3) ] [ Designated as safety issue: No ]
to assess lipid profile. [ Time Frame: At least 12 weeks from baseline (visit 3) ] [ Designated as safety issue: No ]
to assess hypoglycaemias. [ Time Frame: At least 12 weeks from baseline (visit 3) ] [ Designated as safety issue: No ]
to assess changes in weight. [ Time Frame: At least 12 weeks from baseline (visit 3) ] [ Designated as safety issue: No ]
to assess health-related quality of life. [ Time Frame: At least 12 weeks from baseline (visit 3) ] [ Designated as safety issue: No ]
to assess cost-effectiveness of Telecare program vs. common ambulatory program. [ Time Frame: At least 12 weeks from baseline (visit 3) ] [ Designated as safety issue: No ]

Enrollment:	480
Study Start Date:	September 2005
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Telecare system	Drug: Insulin glulisine
2 Self Monitoring Blood Glucose (SMBG)system.	Drug: Insulin glulisine

Eligibility

Criteria

Inclusion criteria:

Diagnosis of type 2 Diabetes Mellitus
Patients treated with combined oral antidiabetic drugs(as fixed combination or simultaneous administration) or with metformin in monotherapy at maximal doses for at least 3 months
Patients having BMI > 25 Kg/m2;
Patients having a HbA1c ≥ 7.5 % and ≤ 11 %
Female patients must be menopausal, surgically sterile, or using effective contraceptive measures;
Female of childbearing potential must use effective contraceptive measures for at least 1 month prior to the entry into the study and should continue to use the same contraceptive method during the overall study period.

Exclusion criteria:

Patients diagnosed with type 1 insulin dependent Diabetes Mellitus;
History of two or more severe hypoglycaemic episodes within the past 3 months or history of unawareness hypoglycaemia;
Active proliferative diabetic retinopathy, as defined by the application of focal or panretinal photocoagulation or vitrectomy, in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require surgical treatment (including laser photocoagulation);
Impaired renal function
Impaired liver function
History of hypersensitivity to insulin or insulin analogues or any of the excipients in the Insulin glulisine and Insulin glargine formulation
History of hypersensitivity to metformin;
Pregnant or breast-feeding women, or women planning to become pregnant during the study;
Failure to use adequate contraception (women of current reproductive potential only);
Any clinically significant major organ system disease such as relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, haematological or other major systemic diseases or infective diseases;
History of drug or alcohol abuse within the last 2 years or current addiction to substances of abuse;
Night shift workers;
Receipt of an experimental drug or use of an experimental device within the 30 days prior to study entry;

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00272064

Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

PAIZIS GEORGES, MD

Sanofi-Aventis

More Information

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	HMR1964A/3514, EudraCT # : 2004-002731-62
Study First Received:	January 2, 2006
Last Updated:	September 5, 2008
ClinicalTrials.gov Identifier:	NCT00272064
Health Authority:	Italy: Ministry of Health

Study placed in the following topic categories:

Insulin glulisine
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009